Fluid Responsiveness in Coronary Artery Bypass Surgery: The Role of Carotid Artery Ultrasound and Passive Leg Raising Maneuver
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ccFT and Hemodynamic Parameters (T4)
研究概览
简要总结
The aim of this study is to investigate the reliability of corrected carotid flow time (ccFT) and the percentage change in peak flow velocity (ΔVpeak), as non-invasive methods for assessing fluid responsiveness using the passive leg raising (PLR) test in patients undergoing coronary bypass surgery.
详细描述
This study is a single-center, prospective, and observational research. After obtaining approval from the ethics committee, 50 patients scheduled for elective coronary artery bypass surgery under general anesthesia at the Cardiovascular Surgery operating room of the Ministry of Health Ankara City Hospital will be included in the study. The study is designed as a single-center, prospective, and observational trial.
Patient data including weight, height, age, gender, BMI (body mass index), ASA classification, left ventricular ejection fraction, comorbidities, and medications will be recorded. Anesthesia induction and management will be performed in accordance with the routine practice of the anesthesia clinic. After the patient is brought to the operating table, in addition to standard hemodynamic monitoring with non-invasive blood pressure (NIBP), 5-lead ECG, and pulse oximetry, bispectral index (BIS), body temperature, and cardiac output monitoring with the Pulsion Flex device will be performed. Parameters measured by the Pulsion Flex device (CI, SVI, SVRI, SVV, PPV, DO2I, dPmx) will be recorded before and after anesthesia induction. General anesthesia will be induced with preoxygenation followed by 0.05 mg/kg midazolam, 1 mg/kg lidocaine, 3 mcg/kg fentanyl, and 2 mg/kg propofol. Muscle relaxation will be achieved with 0.6-0.8 mg/kg rocuronium, and orotracheal intubation will be performed with an appropriate tube. The target BIS value will be maintained within 40-60, and anesthesia will be maintained by adjusting the concentration of volatile anesthetics and remifentanil infusion dose (0.05-0.2 mcg/kg/min) according to hemodynamic parameters.
Ventilation mode and parameters will be set as follows: tidal volume 8 ml/kg based on ideal body weight, respiratory rate adjusted to maintain end-tidal CO₂ between 30-40 mmHg, inspiration/expiration ratio 1:2, positive end-expiratory pressure (PEEP) 5 cmH₂O, and FiO₂ 50%. After Allen's test is performed, radial artery catheterization of the non-dominant hand will be performed for invasive blood pressure monitoring, and a 7 Fr triple-lumen central venous catheter will be inserted into the right internal jugular vein for central venous pressure (CVP) monitoring. These procedures are routinely performed in patients scheduled for open thoracic surgery in our clinic. Preferably, two large-bore peripheral intravenous lines will also be inserted. Measurements will begin once patient preparation is complete, during a hemodynamically stable period, and when spontaneous respiratory effort is absent.
After the patient is placed in a 45-degree head-up semi-sitting position, hemodynamic parameters will be recorded: heart rate (HR, beats/min), systolic arterial pressure (SAP, mmHg), diastolic arterial pressure (DAP, mmHg), mean arterial pressure (MAP, mmHg), stroke volume index (SVI), cardiac index (CI), PPV, and SVV. Corrected carotid flow time (ccFT) and the percentage change in peak velocity (ΔVpeak), measured using Doppler ultrasound, will also be recorded. Ultrasound measurements will be performed with a 4-12 MHz linear probe in vascular mode. With the patient's head tilted 30 degrees to the left, a longitudinal view of the right common carotid artery will be obtained below the lower border of the thyroid cartilage, and measurements will be taken 2 cm proximal to the carotid bifurcation. Doppler will be activated, and the sample volume will be placed at an angle less than 60 degrees in the region with optimal color flow. Flow time will be measured from the beginning of the systolic upstroke to the dicrotic notch.
After one minute of passive leg raising (PLR), hemodynamic parameters as well as ccFT and ΔVpeak will be measured again and recorded. Patients demonstrating a ≥10% increase in CI measured by the Pulsion Flex device after PLR will be classified as fluid responsive, while those without such an increase will be classified as non-responders. The differences in ccFT and ΔVpeak parameters between the two groups will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A total of 50 patients undergoing elective coronary artery bypass surgery under general anesthesia in the Cardiovascular Surgery operating room of the Ministry of Health Ankara Bilkent City Hospital will be included in the study.
- •The volunteers to be included will be patients aged between 18 and 80 years, evaluated as ASA class II-III according to the American Society of Anesthesiologists (ASA) classification.
排除标准
- •Patients who do not wish to participate in the study
- •Patients younger than 18 or older than 80 years
- •Patients with an ASA score greater than III
- •Patients with BMI > 35
- •Patients with EF < 40%
- •Patients with atrial fibrillation
- •Patients with severe valvular stenosis or insufficiency
- •Patients with right ventricular dysfunction
- •Patients with carotid artery stenosis
- •Patients with a history of cerebrovascular accident or transient ischemic attack
- •Patients with increased intra-abdominal or intracranial pressure
- •Patients with glaucoma
- •Patients with severe renal or hepatic disease
- •Patients who develop hemodynamic instability during the perioperative period
研究组 & 干预措施
Study Group
After the patient is placed in a 45-degree head-up position, ccFT will be measured and hemodynamic parameters will be recorded.After passive leg raising, ccFT and hemodynamic parameters will be recorded.
结局指标
主要结局
ccFT and Hemodynamic Parameters (T4)
时间窗: After passive leg raising
After passive leg raising, ccFT and hemodynamic parameters will be recorded.
hemodynamic parameters (T0)
时间窗: before anesthesia induction
After patient monitoring, hemodynamic parameter values will be recorded before anesthesia induction
hemodynamic parameters (T1)
时间窗: after anesthesia induction
Hemodynamic parameters will be recorded after anesthesia induction.
ccFT and Hemodynamic parameters (T3)
时间窗: After the patient is placed in a 45-degree head-up position
After the patient is placed in a 45-degree head-up position, ccFT will be measured and hemodynamic parameters will be recorded.
次要结局
- Delta Vpeak(After passive leg raising)
- Delta Vpeak(After the patient is placed in a 45-degree head-up position)
